Status:

COMPLETED

Nutritional Risk Factors for FASD in Ukraine

Lead Sponsor:

University of California, San Diego

Collaborating Sponsors:

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Omni-Net Ukraine

Conditions:

Fetal Alcohol Spectrum Disorders

Eligibility:

FEMALE

Phase:

NA

Brief Summary

Interventional study randomizing pregnant women at two sites in Ukraine who have or have not already consumed moderate to heavy levels of alcohol in pregnancy to receiving a standard prenatal vitamin ...

Detailed Description

Pregnant women coming in for routine prenatal diagnostic testing or prenatal care at two sites in Ukraine, Rivne Diagnostic Center or Khmelnytsky Regional Perinatal Center, were screened for alcohol c...

Eligibility Criteria

Inclusion

  • currently pregnant
  • reported alcohol consumption 4-5 drinks per occasion on 3-4 occasions in the month around conception or the most recent month of pregnancy, or
  • no more than 2 drinks per occasion in either the month around conception or the most recent month of pregnancy

Exclusion

  • unable to provide consent
  • unable to provide information about alcohol consumption

Key Trial Info

Start Date :

June 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

June 1 2013

Estimated Enrollment :

600 Patients enrolled

Trial Details

Trial ID

NCT03782935

Start Date

June 1 2006

End Date

June 1 2013

Last Update

December 20 2018

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